Results Summary

Topline results indicate statistically significant differences between Acurox with Niacin Tablets (40/240mg and 80/480mg) and the respective equivalent Roxicodone doses (40/0mg and 80/0mg) for the peak liking (Emax) as measured by Like/Dislike scores for 8 hours post-administration (p=0.003 and p<0.0001, respectively). There are statistically significant and clinically meaningful decreases between Acurox with Niacin Tablets and the respective equivalent Roxicodone doses in the Take Drug Again Assessment (at 1, 2, and 8 hours; p<=0.001) and the Global Assessment of Overall Drug Liking (assessed at 12 hours; p<=0.0032). No serious adverse events were reported with the majority of adverse events are consistent with the expected impediment effects of niacin (skin burning sensation, skin warm, and flushing).